Egoropal

GIF decision: Re-authorization for marketing

What does this decision mean?

• Ponowne dopuszczenie do obrotu — The product has been re-authorized for marketing after earlier restrictions.

An out-of-specification result for the particle size parameter was found due to an incorrect limit at a manufacturing process stage (IPC), constituting a quality defect in batch 4201475. Potential effects: altered drug release, risk of lack of efficacy or increased adverse effects.

Download the app and stay informed

Get instant notifications about recalled products and protect your family.

App Store Google Play

Risk Level

Critical

Manufacturer

Egis Pharmaceuticals PLC z siedzibą w Budapeszcie, Węgry

Batch Number

wszystkie serie

Notice Date

28.05.2024

What to do if you have this product?

A recall means the product may be unsafe. Here is what to do if you have it at home.

1

Do not eat or use the product

Stop using or consuming it immediately and keep it out of reach of children.
2

Check the batch number and expiry date

Compare the batch/lot number and the best-before or expiry date with the details in the alert — sometimes only specific batches are affected.
3

Return it to the shop

You can take the product back to the shop where you bought it. For a safety recall a refund is due even without a receipt.
4

Get help and report it

If you feel unwell after using the product, contact a doctor. You can also report the case to the relevant authority — GIS, GIF or UOKiK.

General guidance for recalled products in Poland. Always follow the specific instructions in the official alert and from the manufacturer or retailer.

Important Information

What You Should Know

Recommendations

Do not use product from batch 4201475 (expiry 12.2024); patients should check the batch number on the packaging and, if they have this batch, return it to the pharmacy and consult a doctor if the medi...

Actions Taken

In 2023 the marketing of all Egoropal 75 mg batches was suspended; after investigation batch 4201475 was withdrawn and banned from marketing, and subsequently the suspension decision for the remaining...

Need Help?

If you feel unwell after consuming this product, contact your doctor or call the poison control center.

Egoropal

What to do if you have this product?

What You Should Know

Recommendations

Actions Taken

Need Help?

Other Notices

Teicoplanin AptaPharma

Teicoplanin AptaPharma

Azaneson

Imuldosa

Loperamid APTEO MED